Friday, July 11, 2008

Risks of Suicidal Ideation and Behavior with Epilepsy Drugs Reaffirmed

All epilepsy drugs should carry a warning -- not necessarily boxed -- about increased risks for suicidal ideation and behavior, a joint meeting of two FDA committees concluded here.

In January, the FDA released results of an analysis that found almost double the risk of suicidality with the use of 11 drugs used to treat epilepsy or psychiatric conditions. (See: FDA Finds Suicidal Behavior in Studies of 11 Epilepsy Drugs)

Today, a joint meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee voted overwhelmingly in favor of the agency's conclusions that the finding of increased risk should apply not only to all of the drugs in the analysis, but to all anticonvulsants currently on the market.

The committees also voted to describe the risks in a medication guide that would be handed out to patients who were prescribed the drugs.

However, the idea of including a black box warning on the drugs was rejected. Committee members feared that such a warning would discourage physicians from appropriately prescribing the drugs to those who need them.